EU Regulatory Strategy Leader — Senior Director

100 Eli Lilly and Company; United States; Remote; USD 161,000 - 260,000; Full time

Benefits offered by this job

401(k) matching

Pension plan

Vacation benefits

Medical, dental, vision benefits

Well-being programs

Job summary

Centessa Pharmaceuticals seeks a Senior Director, Global Regulatory Strategy based in the UK to lead European regulatory programs from development to registration and lifecycle management. You will drive submissions, interactions with EMA and national authorities, and multi-regional alignment across teams.

The role emphasizes pediatric regulatory strategy, external partner management, and cross-functional leadership in a fast-paced, matrixed environment. Occasional travel is required.

Qualifications

• 12+ years of progressive regulatory affairs experience within pharma/biotech
• 5+ years in regulatory leadership with significant European experience
• Experience leading European regulatory strategies and submissions (EU, UK, Switzerland)
• Pediatric regulatory strategy and health authority interactions experience

Responsibilities

• Serve as European Regulatory Lead for lead program and other assets, guiding strategy from development through lifecycle management
• Develop and execute regulatory strategies to obtain and expand product registrations in the EU, UK, Switzerland
• Lead planning and submission of MAAs, CTAs, pediatric submissions, and other regulatory filings
• Represent the company in regulatory interactions with EMA, EU NCAs, MHRA, and Swissmedic
• Provide regulatory guidance to cross-functional teams and align development plans with regulatory requirements

Skills

European regulatory leadership

Regulatory strategy

Cross-functional leadership

Pediatric regulatory strategy

Health authority interactions

Regulatory submissions

Education

Bachelor's degree in scientific discipline

Advanced degree (PhD, PharmD, MS, or JD)

Job description

Centessa Pharmaceuticals seeks a Senior Director, Global Regulatory Strategy based in the UK to lead European regulatory programs from development to registration and lifecycle management. You will drive submissions, interactions with EMA and national authorities, and multi-regional alignment across teams.

The role emphasizes pediatric regulatory strategy, external partner management, and cross-functional leadership in a fast-paced, matrixed environment. Occasional travel is required.